MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM-H STD. SIZE 2

Model Number	01.18.132
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 years and 4 months from the primary, the patient came in presenting pain due to a subsided stem and the cause is unknown.The patient reported no trauma.The surgeon revised the medacta liner to a medacta liner and revised the medacta stem and head to a competitor stem and head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 30 march 2026.Stem: amistem h 01.18.132 amistem-h std.Size 2 (k093944) lot 152209: (b)(4) items manufactured and released on 21-jul-2015.Expiration date: 08-jul-2020.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation more than 10 years after primary cementless dm tha, the lady patient is suffering from a subsided stem and revision surgery is undertaken.The image supplied is partial and low quality and does not allow proper evaluation; it seems that the stem is undersized, and this may be due to widening of the femoral canal or to osteolytic bone response, but the partial image does not allow proper evaluation.With the information at hand, we cannot make a definitive statement as to the causes of this late adverse event.Root cause: based on the available information, no definitive root cause can be established.More than 10 years after primary cementless dm tha, stem subsidence occurred requiring revision; however, the limited and low-quality imaging does not allow proper evaluation.While factors such as stem undersizing or bone changes may be involved, no clear device-related issue or manufacturing nonconformity has been identified.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM-H STD. SIZE 2
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24924647
• Report Number: 3005180920-2026-00330
• Device Sequence Number: 13086166
• Product Code: LZO
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2020
• Device Model Number: 01.18.132
• Device Lot Number: 152209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: Black Or African American